Talk CMC & Product Quality track
S0203 - Sustainable Approaches to Product Design, Manufacturing, Testing and Supply Chain Resilience
Thu, Mar 20, 2025 · 10:30–11:40 AM CET Montreal Room, Congress Center Basel
About this session
The purpose is to showcase a range of topics which explore how regulatory frameworks are essential to implement innovation, and secure sustainable supply over the lifecycle of the product. Examples include industry efforts to deliver sustainable manufacturing and supply chains, new analytical technologies and their regulatory challenges, shortage prevention and importation testing.
The presenters and panel discussion will reflect on how flexibility and diligence in regulatory frameworks (such as the Quality requirements in European pharmaceutical legislation, the European variations frameworks) and global reliance for post approval change can all be enablers.
Programme:
- 4. How Current Procedures with EMA Succeeded to Mitigate a Risk of Shortage for an Essential Medicine — Sandra Ducoat
- Panel Discussion
- 2. Sustainability & Supply Chain Resilience Supported by Reliance on Testing Sites Approved by Reference Countries — Joerg Garbe
- 1. Enabling Innovation to Address Sustainability, Environment, and Climate Goals — matt popkin
- 3. Sustainable Approaches to Pyrogenicity and Microbiology Testing
- 5. Supporting innovation, sustainability and resilience in supply of medicines - an EMA perspective — Veronika Jekerle
Speakers
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Head of Pharmaceutical Quality, Quality and Safety, Human medicines · European Medicines Agency
Chair
